Capnographic Monitoring of Propofol-sedation During Colonoscopy

Johann Wolfgang Goethe University Hospital2 sites in 1 country528 target enrollmentJune 2012

ConditionsHypoxia

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Hypoxia
Sponsor: Johann Wolfgang Goethe University Hospital
Enrollment: 528
Locations: 2
Primary Endpoint: Hypoxia (SO2 <90%)
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The present study is a randomized, prospective, single-blinded study. Patients presenting for colonoscopy under sedation will be included according to the statistical sample size calculation. Patients will be randomized to either group 1- capnographic monitoring or group 2- oxygenic monitoring during Propofol-based sedation for colonoscopy. Episodes of Hypoxia are documented and compared in both groups.

Registry

clinicaltrials.gov

Start Date

June 2012

End Date

September 2013

Last Updated

12 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Johann Wolfgang Goethe University Hospital

Eligibility Criteria

Inclusion Criteria

•Indication for colonoscopy
•Patient wishing sedation during colonoscopy
•≥ 18 years of age
•Signed informed consent form

Exclusion Criteria

•Diseases which preclude study accomplishment or put the patient at any risk (e.g. psychiatric diseases)
•Non-contractually capable persons
•Pregnancy
•Lactation

Outcomes

Primary Outcomes

Hypoxia (SO2 <90%)

Study objective is to evaluate if a reduction of hypoxic events (SO2 \<90% for ≥ 15 sec) can be obtained with capnographic monitoring as compared to standard monitoring of respiration with pulse-oxymetry in patients receiving colonoscopy under Propofol-based sedation